Cantab Mobile— 510(k) K161328

Name: FDA 510(k) clearance K161328
Creator: U.S. Food and Drug Administration
Published: 2017-01-13

Substantially Equivalent

Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd.

FDA 510(k) clearance K161328 for Cantab Mobile, Substantially Equivalent on 2017-01-13. Applicant: Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd.. Device class: 2.

Clearance details

Applicant: Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd.
Product code: Code PKQ
Device class: Class 2
Regulation: 21 CFR 882.1470
Advisory panel: Neurology
Date received: 2016-05-12
Decision date: 2017-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bottisham, GB

Download summary PDF View on FDA.gov ↗

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